MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT CHROM 4/0 (2) 75CM HR17; SUTURES

Model Number B0560146

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: preliminary analysis: inventory review: reviewed the available units of this product code / lot number and verifies that to date there are no units in stock.Amount produced / imported: a total of (b)(4) units of the batch were manufactured in reference.Distributed quantity: the units manufactured were distributed to (b)(4) customers from different cities: (b)(4); an export was also made to (b)(4).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 manufacture of the lot was revised and it is verified that the lot had a normal process, no deviations or changes during production are identified.Analysis of the sample (s): have not received any samples and we do not have available units, it is not possible to carry out an investigation that may lead us to the cause of the possible non-conformity reported.In this case a retrospective review of the batch is carried out; (manufacturing and traceability reports of claims related to the lot in question).The documentation for the batch manufacture was reviewed and no deviations or alterations were made during the process.Your information has been entered in our security database and will be included in our trend analysis of this product line.Conclusions: the claim is determined as "unconfirmed", as it is not possible to arrive at a conclusion about the incident presented as it does not have the sample object of the claim.Without any closed samples an analysis cannot be performed to determine if the product fulfills the oem requirements.Actions: no corrective / preventive action is required.

Event Description

Country of complaint: (b)(6).It is reported that the needle is detached from the thread.

• Brand Name: CATGUT CHROM 4/0 (2) 75CM HR17
• 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: 6747724
• MDR Text Key: 81244341
• Report Number: 3003639970-2017-00385
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0560146
• Device Catalogue Number: B0560146
• Device Lot Number: 515173
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/13/2017
• Date Manufacturer Received: 07/06/2017
• 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