MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 4/0(1.5)8X45CM HR22TO(M); SUTURES

Model Number M0022695

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that when the package was opened the needle was on the opposite side of the sponge in the package.All medwatch submissions related to this report are: 3003639970-2017-00135, 3003639970-2017-00136.

Manufacturer Narrative

Samples received: initially (on 08.03.2017) we received three open packs (samples from this complaint and also (b)(4)) but only the aluminum pouch, the support card was not present and thus more samples were requested.On 27.03.2017 54 closed pouches and 4 open were received.Analysis and results: there are two complaints of this reference and batch (this and (b)(4)).Manufactured and distributed (b)(4) units in the market, all to (b)(6).There are no units in stock.The four open units were opened at aesculap (b)(4) to check the product, all four units had the support cardboard incorrectly placed in the pack.Have opened all closed samples received and in 21 of the 54 closed units received the support cardboard is placed in inverted position inside the aluminum pack.Due to this fact, the sutures cannot be pulled out from the pack.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b.Braun surgical requirements.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.Moreover, the personnel involved in the manufacturing of this product will be warned of this issue.

• Brand Name: MONOSYN VIOLET 4/0(1.5)8X45CM HR22TO(M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 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: 6432873
• MDR Text Key: 70824663
• Report Number: 3003639970-2017-00136
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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: 05/12/2021
• Device Model Number: M0022695
• Device Catalogue Number: M0022695
• Device Lot Number: 116194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Distributor Facility Aware Date: 03/06/2017
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• 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