MAUDE Adverse Event Report: RAYNHAM BULK SURG STRIP 1/2 X 6; OEM PATTIES & STRIPS

Catalog Number 245432

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4), the complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.

Event Description

It was reported that the cotton sponge had 11 pieces in a pack normally it should have only 10 pieces in a pack.

• Brand Name: BULK SURG STRIP 1/2 X 6
• Type of Device: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kimberly shelly ; 325 paramount drive; raynham, MA 02767
• MDR Report Key: 8915980
• MDR Text Key: 155086449
• Report Number: 1226348-2019-00341
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245432
• Device Lot Number: J28W65
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1