MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP; EPIDURAL CATHETER

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun melsungen ag internal report # (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 used in products that are sold in the united states by b.Braun medical, inc.We received used catheter and filter, clip, and 2pcs connector out of a perifix filter set.Visual inspection: the catheter is broken 142mm away from tip.The tip of the catheter is kinked and twisted.The catheter was microscopically tested.The catheter resembled a state cut with micro scissors.The catheter is stretched from the tip to the middle.Dimensions check: length: received catheter: 1094mm, standard: 1002.5mm - 1017.5mm, (unused catheter length: 1009mm), the catheter is stretched.We guessed that it was stretched in surgical procedure.Review manufacturing record (perifix filter set).We checked our manufacturing records and any abnormality was not found.We assume a problem during application.This complaint is not confirmed.We have informed our manufacturer of the catheter accordingly and requested a batch review of the involved catheter perifix one.If additional information becomes available, a follow up report will be submitted.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter was broken and the fragment is remained in the patient's body.Patient: (b)(6) years old.Has scoliosis.

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).The catheter is cut off.The area of the cut off is oval and shows a rough structure.We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.We assume a problem during application.The complaint is not confirmed.After checking the respective documentation of the production (shift record, results of worker self-inspection and in-process control, machine documentation, cleaning record etc.) no deviations could be identified in the mentioned time period.

• Brand Name: PERIFIX SOFT TIP
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7837189
• MDR Text Key: 119039803
• Report Number: 9610825-2018-00179
• Device Sequence Number: 1
• Product Code: DQR
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PFS-Y18RW
• Device Lot Number: 18E30H81YR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2018
• Distributor Facility Aware Date: 08/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2018
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR