MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

Catalog Number 910110

Device Problem Crack (1135)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Pr 9388711 initial mdr.A follow up will be submitted if additional information becomes available.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug).

Event Description

Dr.(b)(6) had 3 bottles come apart by squeezing too hard with too much pressure comments on 20/12/2023 1.I am sorry i do not have a sample or photo of the issue.2.The lot number we still have in inventory are: 3234198 and 2311681 3.The product was in use irrigating total joint components when the bottle came apart.

Event Description

Dr.Smith had 3 bottles come apart by squeezing too hard with too much pressure.Comments on (b)(6) 2023.1.I am sorry i do not have a sample or photo of the issue.2.The lot number we still have in inventory are: 3234198 and 2311681.3.The product was in use irrigating total joint components when the bottle came apart.

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause at this time.A production record review was complete for batch/lot 3234198 and no non-conformance was noted during the manufacturing/ packaging of this lot per production records reviewed.A corrective initiation determination was identified which resulted in an overall risk of medium with a severity (s2) and occurrence (o4), the reported issues do not represent a single significant incident that would trigger a capa.No further actions are required.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

• Brand Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Type of Device: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer (Section G): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer Contact: andrew topoulos ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 18425927
• MDR Text Key: 331770496
• Report Number: 1423507-2024-10001
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K221504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 910110
• Device Lot Number: 3234198
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Type of Device Usage: Initial
• Patient Sequence Number: 1