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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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)(4).The device is currently on shipping from (b)(6) for investigation.A follow-up report will be provided after the inspection results are available.Note: this report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient.No intervention was done, and currently there is no serious injury to the patient, so this report has been classified only as a malfunction.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): breakage of catheter.During the removal of the catheter from the back of the patient, the terminal part breaks, remaining in the back itself.

Manufacturer Narrative

Exemption number e2016018.B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used espocan catheter out of a espocan w.Pencan 27gx5" (0,42x127,5 mm) in open packaging.The received espocan catheter was taken to a visual inspection.The catheter is shorn off approximately 970 mm behind the end of the catheter.The shorn off area is slanted and shows a smooth structure.The shorn off part with the catheter tip was not handed over by the customer.Such damages may occur when the catheter will be withdrawn (axial tensile force) against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." therefore we assume a fault during the application process and we consider the complaint as not confirmed.We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8447875
• MDR Text Key: 139700924
• Report Number: 9610825-2019-00088
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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 Expiration Date: 09/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 4556666
• Device Lot Number: 16K23A8701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2019
• Distributor Facility Aware Date: 03/25/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other