MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG SPINOCAN®; SPINAL NEEDLE

Model Number 4502051

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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.

Event Description

As reported by the user facility information by bbm sales organization in colombia: detached needle" according to the complainant during an insertion procedure, the needle was detached and part of the needle stayed in the patient's spinal column.Reportedly the needle fragment is unable to be removed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: a customer complaint regarding cannula bend for pencan 27gx3 1/2" (0.42x88 mm) w.Guide was received.No sample and no picture are provided or returned for further investigation.Measure 1.Investigation was carried out based on complaint description.2.The complaint description stated that during insertion procedure, the needle was detached and part of the needle in patient spinal column.The needle part cannot be possible to be removed.3.The complaint is registered to be packed under batch no: 22m21g8218.Analysis 1.The complaint batch (22m21g8218) was packed at packing machine f41 on (b)(6) 2022.2.Reviewed process card for packing machine f41, no related abnormality was noticed during packing period.Process card 3.As bmi only perform packing process for this product, inspection on this product is only on the packing quality.Reviewed the test report performed by in process quality control, samples from this affected batch had passed all the tests.Final inspection report 4.The pencan needle is a component outsourced from bbaj, bmi only performed packaging process.The assembled needle consists of a pencan needle, a guide needle and a pencan body.5.According to sop regional anesthesia packing procedure (doc.No.: (b)(4)), operator will manually load pencan needle into the blister, then the needle loaded blister will be sealed and packed into duplex boxes and then into carton boxes.The carton boxes were then sent to eto sterilization and ready for shipping.6.The process line is reviewed and the potential root cause for this defect 7.As shown in figure 1, the cannula is protected by the protective cap up to the gluing attachment in point site a for guide needle and gluing in white site b for pencan.Moreover, there was no direct contact between the operator and the cannula up to the gluing attachment in point site a for guide needle and gluing in white site b for pencan during the manual loading process.The protective cap will not be removed during the packing process.Hence needle loading was ruled out of the potential root cause.Figure 2: packing process 8.Therefore, there is no possibility that this defect was generated during packaging process in bmi.9.The potential root cause for this defect could not be determined in bmi after reviewing the whole packaging process.10.As there is neither sample nor picture available for further investigation, this complaint is not confirmed.However, since pencan is a product outsourced from bbaj, this case will be forwarded to bbaj for further investigation.Summary of root cause analysis: a customer complaint regarding raw cannula bend for pencan 27gx3 1/2" (0.42x88 mm) w.Guide was received.No sample and no picture are provided or returned for further investigation.The complaint description stated that during insertion procedure, the needle was detached and part of the needle in patient spinal column.The needle part cannot be possible to be removed.The cannula is protected by the protective cap up to the gluing attachment in point site a for guide needle and gluing in white site b for pencan.Moreover, there was no direct contact between the operator and the cannula up to the gluing attachment in point site a for guide needle and gluing in white site b for pencan during the manual loading process.The protective cap will not be removed during the whole packaging process.Therefore, there is no possibility that this defect was generated during packaging process in bmi.The potential root cause for this defect could not be determined in bmi after reviewing the whole packing process.As there is neither sample nor picture available for further investigation, this complaint is not confirmed.However, since pencan is a product outsourced from bbaj, this case will be forwarded to bbaj for further investigation.Cause : cause could not be determine 1.The cannula is protected by the protective cap up to the gluing attachment in point site a for guide needle and gluing in white site b for pencan.There is no direct contact between operator and the cannula during the manual loading process as the protective cap will not be removed during the whole packing process.2.After reviewing the whole packaging process, the potential root cause for this defect could not be determined in bmi.3.As pencan is a product outsourced from bbaj, this case will be forwarded o bbaj for further investigation.Corrections/containment plans with effective date: 1.Not applicable as the physical pencan stock of complaint batch 22g26h0bp1 is no longer available in bmi inventory.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.

• Brand Name: SPINOCAN®
• Type of Device: SPINAL NEEDLE
• 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: 18439810
• MDR Text Key: 331865088
• Report Number: 9610825-2023-00646
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4502051
• Device Lot Number: 22M21G8218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2022
• 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): Hospitalization