MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	305060
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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 3ml ll w/ndl 18x1-1/2 blunt fill package was damaged / defective.The following information was provided by the initial reporter: material # 305060 batch # unknown verbatim: rcc received a complaint via email.Email(s) attached.We have received a quality complaint on product sold to our customer.Please contact the customer, cc **** and include complaint # (b)(4) on any future communications.Injuries or adverse event: no item: 305060 quantity affected: (b)(4) boxes serial/lot number: n/a po : (b)(6).Are any samples available for return? yes reported issue: the va received 1 box of item b-d305060 and in the box the pictures below were found.The box did have the majority sealed in packages, however, the 5 syringes were not sealed in any package.Customer disposition request: replacement.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - package damaged / defective / other.Correction: following the submission of the initial mdr, the batch number was corrected from ¿unknown¿ to 5182762.Evaluation: five samples and two photos of 3 ml luer-lok syringes (part number 305060, batch 5182762) were received for evaluation.The syringes were loose, with one showing a cut barrel and plunger rod near the bd logo.Packaging issues included one empty package with an open seal and three top web slips that were partially cut.Photos confirmed the loose syringes and damaged packaging.These conditions do not meet product specifications.A defect notification was issued during production, and requalification cleared the line; however, some defective units may have escaped detection.The likely root cause of the damaged packaging, compromised seal integrity, and barrel damage is linked to the slitter area of the packaging process.Complaints related to this device and condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and our business team regularly reviews this data to identify emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: PLASTIPAK LUER-LOK
• Common Device Name: 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: 23538778
• Report Number: 1213809-2025-00710
• Device Sequence Number: 9457957
• Product Code: FMF
• UDI-Device Identifier: 00382903050604
• UDI-Public: (01)00382903050604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 305060
• Device Lot Number: 5182762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown