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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional 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).Investigation was based on the complaint description and returned sample.1 piece of pencan was returned in opened packaging.Visually inspected the returned sample, no dented or crack was noticed on the protective cap.Pencan needle was inspected under smart scope and jagged end was found at the broken point of pencan needle.The defect caused by packing machine can be ruled out.Reviewed process card, no abnormalities was found during this packing period.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in malaysia): spinal needle broke.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4) (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).Pencan was assembled in bbraun aesculap japan (bbaj) and packed by bbraun medical insdustris (bmi).There was no direct contact between operator and the pencan needle because pencan needle was capped with protective cap.Besides, the cap was not remove during packing process and by inspected the returned sample, no dented or crack protective cap was noticed.Hence the defect caused by packing machine can be ruled out.Additionally, bbraun aesculap japan (bbaj) batch manufacturing and process card record shows no abnormality.Bbraun aesculap japan (bbaj) stiffness test showed all passed.Therefore there was no possibility that such defect is due to our manufacturing process.Thus this case is not confirm.As the situation described, "a hypodermic needle was used as an introducer before the insertion of the spinal needle (pencan g27 3 1/2)", as per "instruction for use" booklet specified the recommendation to select a suitable spinal needle and use an introducer needle for spinal needles less than 25g diameter.Additionally, at warning section stated "the needle might bent and eventually break when applying too strong forces during advancement.The tip of the tip of the needle becomes blunt or can even split after bone contact".Hence, suspected the broken pencan needle occurred possibly due to the handling during the procedure.

• Brand Name: PENCAN
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8084409
• Report Number: 9610825-2018-00249
• Device Sequence Number: 13717697
• Product Code: MIA
• UDI-Device Identifier: 04046964180941
• UDI-Public: (01)04046964180941(17)230301(10)18C21G8F03
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K112515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019
• Report Date (Section F): 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 4502027
• Device Lot Number: 18C21G8F03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/02/2018