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

Catalog Number 4502043-13

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number: (b)(4).The complaint is under investigation.A follow-up will be provided after the investigation 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 (translation of user facility information by bbm sales organization in germany: "needle broken off." "needle broke off during spa l3/4 (sectio), the needle tip (approx.4cm long) remained in the patient's body and was surgically removed from the back muscles.All material has been secured and is available.Unfortunately we were unable to salvage the original packaging of the broken needle from the waste, attached is a photo of the packaging of an identical needle from the same order.The incident occurred on (b)(6) 2023 at around 08:39 according to the op protocol.As things stand at present, we are unable to make any statement on the patient's state of health, as she left our premises on her own responsibility on (b)(6) 2023.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).We received one used pencan 25gx3 1/2" (88mm)m.Fk-eu/ap/sa without packaging.The received used sample was taken to a visual inspection for damages according to the test method damages.The used pencan cannula is broken off and bent approx.48 mm near the cannula hub.The area of the break from the raw cannula shows that the cannula was bent before the break.There is also a pressure point in the cannula.Afterwards, the outside diameter of the pencan cannula was measured according to drawing.Nominal-value: 0.53 mm +0.01/-0 mm.Actual value: 0.53 mm.The measured value (outside diameter) of the pencan cannula is within the specification.We assume of a problem during the application process.Bending stiffness test has been conducted on the retention sample of cannula tubes.Material no.: 4502043-13.Batch no.: 22m18h8b01.Spec: max 0.43mm.Result: 0.310mm pass.Any abnormality in the history record was not confirmed.Based on the conducted investigations the tested sample is within the specification.Therefore, the complaint is considered as not confirmed.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: PENCAN®
• 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 ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17121362
• MDR Text Key: 317123335
• Report Number: 9610825-2023-00261
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4502043-13
• Device Lot Number: 22M18H8B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention