MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; I.V. SAFETY CATHETER

Model Number 4251628JP

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Bmi complaint management dated (b)(6) 2023.Device history record (dhr): reviewed the device history record for batch number 22l01g8316 and there were no defect encountered during in process and final control inspection.Note: awaiting for sample from bbaj.Samples receipt at bmi - complaint investigator, dated 2023-08-07.Bmi preliminary investigation: received 34 pieces of introcan safety pur 22g, 0.9x25mm-ap (1 in an opened packaging | 33 in original packaging).Lot number printed on returned peel packs are 22l01g8316 and material# 4251628jp.Based on test spec #: hc-my01-m-5-4-10-027-0 (test specification - introcan sterile), ten (10) samples were taken to a visual test according to test method 102000 (visual) | test method 102002 (damages) and no damages or other abnormalities observed on the ten samples.Note: forwarded all samples to production for further evaluation and investigation.Dhr reviewed.Task for (b)(4): samples receipt at bmi.Status: task completed.Oqcm dated : 2023-08-07.Task for fatin aslinda abu talib: awaiting statement.Status: task completed.Root cause analysis: machine production completion date.Packing s/packet : 12114849.Packing machine : f.Eto channel: ch.Final shop packet no: 12114890.Batch: 22l01g0015 & 22k30g0089.Article no : 4251628up1.Cam d376: 2022-10-17.Cal d377: 2022-10-17.Ecm d375: 2022-10-18.Process cards show no abnormalities.Trend analysis: customer complaint of clip function - failure to engage for introcan safety trend analysis is being tracked based on capa initiation criteria.Sample received: received total 34pcs of introcan safety pur 22g, 0.9x25mm-jp (33pcs in original packaging, 1pc in an opened packaging) with batch 22l01g8316 and article # 4251628jp.Sample test plan all 34 pcs sample (33pcs in original packaging, 1pc in an opened packaging) were subjected test as per test plan below under etr ewlh-cugcvp.(refer to cir).All samples passed for all tests above, refer to attached etr report.(refer to cir).Review of safety clip historical ipqc inspection data safety clip batch details: 22g02g0dxe, 22g03g0dxg, 22h18g0dxa, 22h19g0dxb.Description: sideflap clip 22g (v2).Clip article no: 15323631.(refer to cir).The stamping ipqc data for the clip batches used in the possible complaint batches showed no deviation and all measurements were within the specification.Review of raw cannula's historical inspection data cannula batch details: 21f03g0109, 22g09g0103.Description: universal bevel int.Ca.For 22g x 25 (ef).Cannula article no: 15325221.(refer to cir).The raw cannula data used in the possible complaint batches showed no deviation and all measurements were within the specification.Review of process card: the complaint batch was produced at braun 3 introcan line 4.(refer to cir).Process cards for machine above were reviewed.No abnormality observed.Review of assembly process flow.Introcan cannula assembly machine (cam) (refer to cir).Introcan end control machine (ecm) (refer to cir).Review on production process flow was performed.Both cam & ecm machines have online vision system to conduct 100% checking on relevant critical dimension of cannula and clip including crimp width, crimp length, clip dimension, clip position and bevel condition.All the defective parts will be automatically rejected by machine.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated immediately.Beside the automated 100% in-line test equipment independent in-process quality controls and final controls on a random sample basis will be conducted by different teams on a regular basis within the production process.Herewith a systematic product defect would be detected.Review of final control inspection results test specification: introcan sterile (doc.No: (b)(6) (refer to cir).Final control test results for 22l01g8316 were reviewed.All results were reported as passed.Final control test result: 1.Withdrawal force: specification: 0.1 - 2.0n.Final control withdrawal force test result was reviewed.Result was reported as passed.2.Drag force: specification: max 0.6n.Final control drag force test result was reviewed.Result was reported as passed.3.End force: specification: max 1.0n.Final control end force test result was reviewed.Result was reported as passed.Review of ipqc inspection results: ipqc inspection results for damage (for bbaj), assembly defect (for bbaj), glue level on cannula, clip position of finished goods according to drawing, safety clip function (90 degree rotation), withdrawal force, drag force, end force, slanting cannula, crimp width and crimp length for assembly shop packet 12114890 were reviewed.The results were reported as passed.Ipqc and final control holdback record was reviewed.No damage or failed clip function related holdback reported for complaint batch 22l01g8316.Summary of root cause analysis: received total 34pcs of introcan safety pur 22g, 0.9x25mm-jp (33pcs in original packaging, 1pc in an opened packaging) with batch 22l01g8316 and article # 4251628jp.All samples were inspected and tested by bmi.The samples passed the tests conducted and they meet the specifications.Process card was reviewed.No abnormality during manufacturing of the complaint batch 22l01g8316.Assembly process flow was reviewed.Both cam & ecm machines have online vision system to conduct 100% checking on relevant critical dimension of cannula and clip including crimp width, crimp length, clip dimension, clip position and bevel condition.All the defective parts will be automatically rejected by machine.Final control and ipqc visual inspection and functional test results was reviewed for batch 22l01g8316.All results were reported as passed.This complaint is concluded as not confirmed.Cause : cause could not be determine.The returned samples have been checked and tested by bmi.The samples passed the tests conducted and they meet the specifications.Review of process card and final control record showed no deviation during manufacturing process and final control inspection.Therefore, this complaint is concluded as not confirmed.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.

Event Description

As reported by the user facility information by bbm sales organization in japan: "needle stick injury." according to the customer: safety mechanism was no worked properly and needle stick injury happened to the nurse who took care of.The actual product is not going to be provided.According to the customer, there was a safety clip in the actual product but it did not work properly and stopped in the middle of the needle.After use for the patient, the actual product was put on the kidney tray and the needle stick injury was occurred when other nurse was putting the actual product away.The cusomer provided 34 unused product from same batch for investigation.(1 out of 34 was opened but unused.) please carry out the investigation with unused samples.No infection/possibility of health hazard (inspection for the nurse is being carried out)/ unused samples from same batch were available (not actual product).".

• Brand Name: INTROCAN SAFETY®
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17646208
• MDR Text Key: 322221307
• Report Number: 9610825-2023-00402
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251628JP
• Device Lot Number: 22L01G8316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other