MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 1 (4) 8X45CM HRB48; SUTURE

Model Number M0024876

Device Problem Defective Device (2588)

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

Event Date 05/14/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(4).Six packs of this product were used in a surgery (urology).When the customer counted the used needles after the surgery, he found that there were 49 needles.Theoretically, 48 needles are correct quantity, because 8 needles x 6 packs.X-ray exam was performed to the patient and nothing found.

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 19 unopened units of the batch 114222 and 24 unopened units of the batch 114372.There are two possible batches affected: 114222 and/or 114372.There are no previous complaints of either code-batch.There are no units in stock of these batches.All the closed samples received were reviewed and all of them have 8 sutures, which is according to the specifications of the product.We have not received any complaint of this article concerning incorrect quantity inside the package.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.Corrective/preventive actions: not applicable.

• Brand Name: MONOPLUS VIOLET 1 (4) 8X45CM HRB48
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; rubi (barcelona) ; SP
• 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: 4845228
• MDR Text Key: 5932227
• Report Number: 2916714-2015-00484
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031216
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0024876
• Device Catalogue Number: M0024876
• Device Lot Number: 114222
• Date Manufacturer Received: 05/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other