MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 10ML LL W/NDL 21GX1IN; PISTON SYRINGE

Catalog Number	30964220
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 10ml ll w/ndl 21gx1in had leakage past the stopper.The following information was provided by the initial reporter: "we had a clinic file a complaint for faulty bd 10 ml syringe luer-lock tip with bd precision glide needle.The clinic reported that multiple syringes were leaking from the stopper.There was only one clinic who reported this issue at this time." please see product and lot information below product: 10 ml bd luer-lok¿ syringe with attached needle 21 g x 1 in.Mfr part #: 30964220 lot#: 3233242 can you please forward/share with the appropriate parties from bd to address this issue.Also, have you heard of any other customers complain about this product/lot number.Additional information provided on 02/21/2024: 1.Can you please provide a exact date of event? a.I believe monday, (b)(6) 2024.2.Could you please provide a further description of the issue? a.Multiple syringes leaking from stopper ¿ same lot: 3233242.3.Where specifically was the leakage? a.Stopper.4.Were there any noticeable defects on the luer / stopper / connection / needle? a.Not to my knowledge.5.If past the stopper, was it all the way past the stopper or only within the ribs of the stopper? a.It was at the stopper.6.What was being used in the syringe? a.I¿m not sure.7.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? a.No, not to my knowledge.8.Is there a photo or sample available showing the reported issue? if yes, are you able to provide the address of the facility for us to ship the return label? a.No, not to my knowledge.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 10ML LL W/NDL 21GX1IN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18865110
• Report Number: 9614033-2024-00025
• Device Sequence Number: 16975647
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: Other
• Device Catalogue Number: 30964220
• Device Lot Number: 3233242
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown