MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X3 -200; SURGICAL PATTIES

Catalog Number 801407

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a surgical pattie has a small brown stain on it.No additional information was provided.

Manufacturer Narrative

Failure analysis: the surgical pattie (801407) was not returned for evaluation as the facility has kept and is holding on to the pattie product and we do not expect to receive it.Lot number information has not been provided; therefore, device history record (dhr) could not be reviewed the root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Root cause: per the complaint background, brown stain.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A risk assessment and trending were performed as part of the evaluation.Product was not received for analysis and the investigation could not confirm the complaint.It is noted that this facility has had two other complaints that were confirmed as burn marks and they stated that this was the ¿same event¿.If these were indeed burn marks (unable to confirm without the physical product), then the potential root cause would be machine error or operator error.The risk remains acceptable per the risk analysis.Corrective/preventative action has been implemented to further investigate failures for the patties/strips product family which relate to discoloration.

Event Description

N/a.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12664710
• MDR Text Key: 277370083
• Report Number: 3014334038-2021-00217
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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 Catalogue Number: 801407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/11/2021
• 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