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

Catalog Number 4502124

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen (b)(4) internal report # (b)(4).Sample evaluation: received 1 piece of pencan 27gx4" (0.42x103 mm) w.Guide in opened packaging together with a peel paper with batch no.16m25g8216.Upon visual inspection, the pencan cannula was broken off.No abnormalities observed on the mandrin and the guide needle.Bmi device history record (dhr): reviewed the dhr for the batch no.16m25g8216, no abnormalities observed during the in-process and final control inspection.Bmi root cause analysis: pencan product was assembled at bbaj and bmi performed packaging as a finished goods.According to sop, operator manually load pencan needle into the blister.Pencan needle was capped with protective cap and will be sealed and packed into duplex box and then into carton box.There was no direct contact between operator and the cannula during loading process.As pencan is manufactured by b.Braun aesculap (b)(4), this complaint was forwarded to bbaj for further investigation.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 (b)(6)): broken needle.The broken piece had to be removed by a surgeon.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Bbaj investigation results: we received pencan needle g27 x 4" (g27x103) [1].The following investigations were conducted: visual inspection: cannula of the bulk needle was fractured 58.0mm from the hub base.The mandrin was slightly bent but not fractured.There was no abnormality with the guide bulk needle received with the sample.It is speculated the cannula was fractured due to repetitive bending as there was thinning observed from the point of fracture.The fracture surface is similar to that of a sample that was deliberately fractured from repetitive bending.There is no process during the manufacturing of the cannula nor during transportation where the cannula is bent.Function inspection: stiffness test, test conducted using retention sample, pencan bulk.0.42x103(sp,gid), mat.No.8419620, bat.No.16c14h0bp5, company specifications: max 0.65mm, span: 7.5mm, test load: 5.5n, results: 0.346mm (pass).Device history review: no abnormalities found from reviewing the batch records for batch no.16c14h0bp5.Summary and assessment: based on the conducted investigations the samples are within the specification.Therefore the complaint is considered as not confirmed.

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTH
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen,
• MDR Report Key: 9713069
• MDR Text Key: 183158831
• Report Number: 9610825-2020-00028
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: 4502124
• Device Lot Number: 16M25G8216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention