MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 10/0 (0.2) 15CM DRM5; SUTURES

Model Number G1118110

Device Problems Break (1069); Product Quality Problem (1506)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6) (importer) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number:(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The description of the article number doesn´t match the suture itself.The suture suppose to be black, but instead it is undyed.So there must be some mistake in the batch.And it breaks a lot easier than the black ones.

Manufacturer Narrative

Samples received: 6 unopened and 1 open units.Analysis and results: there are no previous complaints of the same batch.We manufactured and distributed in the market 348 units of this batch.There are no units in our stock.We have received six closed samples and one open and unused sample (only the second pack is open).We have checked the samples received and all have inside an undyed thread instead of a black thread (as in the product description).The thread diameter corresponds to usp 10/0 size and the thread length is 15 cm (as in the product description), but the color does not correspond to the product description on the other hand, we have tested the knot pull tensile strength of the samples received and the results do not fulfil the requirement.Also, linear tensile strength results conducted with the samples received do not fulfil the requirement.Corrective/preventive actions: an internal nonconformity has been opened in order to determine the root cause of this issue and avoid happen in the future: inc qa 122/17.

• Brand Name: DAFILON BLACK 10/0 (0.2) 15CM DRM5
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6876771
• MDR Text Key: 87349083
• Report Number: 3003639970-2017-00461
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K990090
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: G1118110
• Device Catalogue Number: G1118110
• Device Lot Number: 117193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2017
• Date Manufacturer Received: 08/22/2017
• 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