MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT PLAIN 4/0 (2) 75CM HR22; SUTURES

Model Number B0530301

Device Problems Failure To Adhere Or Bond (1031); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the suture had leakage from the pouch and the needle was detached.

Manufacturer Narrative

Samples received: 3 closed, unused envelopes with sterilizing solution are received.Preliminary analysis: · stock review: we proceed to review the stock of this product code and lot number and verifies that to date there are no available units.· quantity produced / imported: a total of (b)(4) of the reported batch were manufactured.· background: the claims database was reviewed and it was confirmed that there is no report related to this product code and lot number.· batch record: the documentation corresponding to the production of the batch was reviewed and it was verified that the batch had a normal process, no deviations or alterations were identified during production.Analysis of sample (s): the samples received were visually checked and it was possible to identify that the three units were without the sterilizing solution; this was caused by an anomaly in the manufacturing process, which is not detectable in the final control and affects a minimum percentage of the lots; for this defect a corrective action was created (b)(4).In relation to the disassembly, it is not possible to perform an analysis with the samples received since they have no liquid and this causes the product conditions to change.We take as reference the data in relation to the strength of the assembly made for the batch release and the results obtained comply with the usp and the requirements of b.Braun.Results: average: 1.32 kgf., minimum: 0.96 kgf.(reference value usp average 0.45 kgf).Actions: no action is required, since the fault that caused the cause reported in the claim was corrected long before receiving this report.

• Brand Name: CATGUT PLAIN 4/0 (2) 75CM HR22
• 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: 6695362
• MDR Text Key: 79515739
• Report Number: 3003639970-2017-00356
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K991223
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0530301
• Device Catalogue Number: B0530301
• Device Lot Number: 516031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/03/2017
• Date Manufacturer Received: 06/13/2017
• 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