MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN UNDYED 5/0 (1) 45CM DSMP13 (M); SUTURES

Model Number C0023603

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint:(b)(6).There is a monosyn's packaging discrepancy and the faulty product is monosyn 5/0 dsmp (b)(4).The incident happened in pediatric surgery and opened by a scrub nurse.Mix-up: wrong product inside 1st pack.

Manufacturer Narrative

(b)(4) is submitting this report on behalf of b.Braun surgical (b)(4).Manufacturing site evaluation: samples received: none, pictures.Analysis and results: there are two previous complaints of the same code batch.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Received one picture which shows two open samples, one of them was usp 3/0 instead of usp 5/0.There was a mix-up of product inside the pouches.The other open sample of the picture received is correct, according to the printed information on the pouch.The mix-up took place in the manufacturing line, clean line was not performed.Final conclusion: complaint is justified.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.Corrective/preventive actions: according to the internal procedures, corrective or preventive actions has been implemented through oem.

• Brand Name: MONOSYN UNDYED 5/0 (1) 45CM DSMP13 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5183537
• MDR Text Key: 29610073
• Report Number: 2916714-2015-00945
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: C0023603
• Device Catalogue Number: C0023603
• Device Lot Number: 111173
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other