MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL BD¿ ALLERGY SYRINGE; SYRINGE, PISTON

Catalog Number	305539
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during a catheter integrity check, a drop of blood and drug solution mixed together was observed.There seemed to be a crack through which a drip is detected: the drug solution passes into this crack and not into the patient¿s vein.There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
Investigation summary: the returned used unit has been visually inspected and tested for leakage, confirming a leakage in correspondence of the cut located at the base of the catheter near the area where the catheter has been folded.As shown in the picture provided by the customer, the catheter has been used and it was folded, probably clamped at some point, while in use for the medical treatment as suggested by the pocket of blood on it.It is not possible that the catheter was already folded/clamped before its opening/use since it would not have been possible to have a needle already inserted into as foreseen by the blistered product.Otherwise, the customer would have noticed it and would have been unable to use it regularly.In addition, the defect is a cut not compatible with a type of damage caused by the assembly machine stations or manufacturing process.Most likely, during the catheter inserting/needle removal procedure, the catheter has been clamped with a sharp tool, such as tweezers, to avoid the came out of blood during the timeframe where the catheter is safely connected to iv administration line.This caused the small cut that was noticed later during the catheter integrity check reported by the customer.Review of the manufacturing process confirms that the product is checked for any damage that could affect its functionality and for leakage within the in-process qc tests specifically through the following tests: - catheter water leakage test: the fluid tightness between the components of a sub-assembly subjected to hydraulic pressure is checked to ensure no leakage occurs.- damaged nonfunctional product: the product is visually inspected for any damage that would affect the safety or functionality of the acam assembly, this includes inspection for punctured catheter.Review of the dhr (device history record) showed that no nonconformance was raised that could pertain to the defect reported.A review of the complaints database has been performed showing no other complaints on the lot involved.The review has been extended to all the lots belonging to the product code 305539 showing no other complaint ever received.Probable/root cause: product misuse.Based on the evidence available, the reported allegation is not confirmed therefore no action will be implemented at this time.Complaints data will continue to be monitored.

• Brand Name: BD¿ ALLERGY SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20453692
• Report Number: 3004187702-2024-00044
• Device Sequence Number: 7204217
• Product Code: FMF
• UDI-Device Identifier: 00382903055395
• UDI-Public: (01)00382903055395(17)260925(10)4435298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2026
• Device Catalogue Number: 305539
• Device Lot Number: 4435298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown