MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; NEEDLE, CONDUCTION, ANESTH

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as event two of b.Braun internal report number (b)(4).We received no sample nor some relevant / significant pictures for investigation.Therefore, an examination / root cause analysis was not possible.Retained sample investigation: functional test: no abnormality was identified.Bending stiffness test was conducted on the retention sample of cannula tubes in accordance with the valid testing and measuring method.Inspected item: pencan 25gx4 w.Intro.-eu/ap.Material no.: 4502116-13xx.Batch no.: 20d21h8b05.Result: 0.381 mm.Judgement: passed.Conditions of testing: span: 10.0 mm, test load: 7.0 n, specification: max 0.43 mm (thin walled tubing).Review manufacturing records: we investigated our manufacturing records of the concerned batches of bulk needles, but any abnormality was not found.Justification: this complaint was not confirmed.We received no complaint sample.Therefore, we conducted the review of the manufacturing record of the concerned batch of the bulk needle.Also, the visual inspection and the bending stiffness test for the cannula tubes using the retention sample were performed accordingly.Result: any abnormality was not confirmed as a result of reviewing the manufacturing record of the bulk needle.No abnormality was identified as a result of the visual inspection of the retention sample.Result: 0.381 mm, specification: max 0.43 mm (thin walled tubing), span: 10.0 mm, test load: 7.0 n, judgement: passed.It was confirmed that the inspected samples satisfied the specification of the bending stiffness.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): event 2.Needle-damaged-broken.The needle has broke just after the bevel.Half of the needle has remained in the interspinous space.The broken part has been recovered.No sample available.

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11020433
• MDR Text Key: 221797122
• Report Number: 9610825-2020-00339
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4502116-13
• Device Lot Number: 20D21H8B05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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): Required Intervention