MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0 (1.5) 45CM DS19 (M); SUTURES

Model Number C0024909

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: one open pouch.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in the warehouse.Received an open unused pouch labeled as monosyn violet 3/0 45 cm dsmp19 needle.Batch number is unknown as the part of the packaging that contains the information is missing.The order previous to the packaging of the monoplus violet 4/0 45 cm ds19 (c0024909) batch 117393 corresponds to a monoplus violet 3/0 45 cm dsmp19 (c0024109 batch 117392).Both products were packed one after the other by the same operator.It was assume that clean line in the manufacturing process was not performed correctly and one unit of the previous order was packed in the first box of the next order.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: taking into account that the results of sample received does not fulfill the oem specifications, it is concluded that the complaint is justified.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.Automatic packaging improvement on going will prevent this kind of issues.

Event Description

Country of complaint: (b)(6).It was reported that when the customer opened one box, one unit different product was in the box.(different product is 3-0 standard).

• Brand Name: MONOPLUS VIOLET 4/0 (1.5) 45CM DS19 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7245680
• MDR Text Key: 99326856
• Report Number: 3003639970-2018-00067
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031216
• 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
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024909
• Device Catalogue Number: C0024909
• Device Lot Number: 117393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Distributor Facility Aware Date: 01/31/2018
• Date Manufacturer Received: 01/17/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other