MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. CATGUT CHROM 2/0 (3.5) 75CM HR37S; SUTURE

Model Number B0563960

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle size larger than it should be.

Manufacturer Narrative

Mfg site eval: eval on-going at mfg site.

Manufacturer Narrative

Manufacturing site evaluation: samples receive: 57 unopened units.There are no previous complaints of this code batch; (b)(4) units of this code batch were manufactured, there are no units in stock.Needle dimensions of the closed samples received were checked and all of them comply the specifications of the product.At the time of production, this reference contained two different needle references approved to be used in this product.Both needles references were a hrt37s needle but with slight differences in the curvature that could be detected by the user.Currently, there is only one needle reference approved to be used in this product to avoid needle differences in product.Final conclusion: not justified.Corrective/preventive actions: not applicable.

• Brand Name: CATGUT CHROM 2/0 (3.5) 75CM HR37S
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona) 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4617963
• MDR Text Key: 5652851
• Report Number: 2916714-2015-00174
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K991223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2015

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 Model Number: B0563960
• Device Catalogue Number: B0563960
• Device Lot Number: 611085
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: No
• 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