MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS; UNKNOWN FOLEY TRAY

Device Problem Fracture (1260)

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that customer had an issue with one of the syringes being cracked in one of their foley kits.When customer opened it, everything looked normal, and nothing was out of the ordinary.They did not notice anything wrong until they attached the syringe with saline and began to push it.At that time saline sprayed everywhere through the crack in the syringe.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

The reported event is confirmed - cause unknown.Received one (1) syringe.Visual inspection noted the syringe was cracked.This does not meet specification per which states "no cracks, warped barrels, or plungers allowed".Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be incorrect clearance by machine maintenance.However, there was insufficient information to confirm this potential root cause.A dhr review is not required as the lot number is unknown. the product catalog number is unknown; therefore a labeling review cannot be performed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that customer had an issue with one of the syringes being cracked in one of their foley kits.When customer opened it, everything looked normal, and nothing was out of the ordinary.They did not notice anything wrong until they attached the syringe with saline and began to push it.At that time saline sprayed everywhere through the crack in the syringe.Per follow up response received via email on 12apr2024, customer stated it was the only lot that they had issue with.There was not any additional impact from this event.

• Brand Name: FOLEY TRAYS
• Type of Device: UNKNOWN FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18874493
• MDR Text Key: 337739771
• Report Number: 1018233-2024-01230
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/25/2024
• 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