MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL EURO 200 S/C; PISTON SYRINGE

Catalog Number 309658

Device Problems Fracture (1260); Defective Device (2588)

Patient Problem Chemical Exposure (2570)

Event Date 09/29/2023

Event Type  malfunction  

Event Description

It was reported that the syringe 3ml ll euro 200 s/c had a crack.The following information was provided by the initial reporter, translated from french to english: "the syringe was prepared in the cru by the hospital pharmacy staff (cytotoxic sample taken and safety cap added) without any problems, but when the patient was given the sc syringe, a crack was noticed on the syringe when the cytotoxic leaked and dripped (a few drops) onto the patient's clothes and the nurse's gloves.As a result, a cytotoxic syringe had to be prepared again in the cru, and the patient and the nurse were exposed to the anticancer drugs." the following information was received on 11/7/23, translated from french to english: "no adverse effects or medical intervention to date, the nurse had a few drops of anti-cancer medication on her gloves which were changed, the patient the same thing on her pants, she did not report any problems afterwards.However, general exposure through inhalation or dermal passage cannot be ruled out.".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Pr (b)(4) ¿ follow up mdr for device evaluation.No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10 manufacture narrative.

Event Description

Updating annex a code to better reflect the event.

Manufacturer Narrative

Pr (b)(4) - follow up mdr #2 for a correction.Following the submission of the initial mdr, it was determined that the annex a code should be updated to more accurately reflect the failure.Annex a code changed from a0203 to a040103.

• Brand Name: SYRINGE 3ML LL EURO 200 S/C
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18143924
• MDR Text Key: 328510047
• Report Number: 1213809-2023-01277
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096580
• UDI-Public: (01)30382903096580
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309658
• Device Lot Number: 1229201
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female