MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL VIOLET 3/0(2)8X45CM HR26 TO (M); SUTURES

Model Number M1078171

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open pack.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 one open and used pack.It has one suture still placed in the support sponge and nine needles (mostly detached, some with a piece of thread) attached to a separate sponge.Checked the support sponge where the needles are placed in the pack and it could be seen two spots with a bigger hole in the sponge that could be caused by two needles (sutures) in one spot.The root cause is determined to be a human error by the operator that winds the sutures in the pack.The operator placed two sutures in two spots making a total count of ten sutures in the pack.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.Artificial vision system that counts the number of needles in the involved pack was not yet implemented in this order.

Event Description

Country of complaint: (b)(6).The customer found that 10 sutures in one pouch after using 8 sutures in an operation.

• Brand Name: SAFIL VIOLET 3/0(2)8X45CM HR26 TO (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: 7267080
• MDR Text Key: 100139666
• Report Number: 3003639970-2018-00073
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: M1078171
• Device Catalogue Number: M1078171
• Device Lot Number: 117274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Distributor Facility Aware Date: 02/01/2018
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/13/2018
• 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