MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309657

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 2 bd 60ml syringe luer-lok¿ tips experienced leakage.The following information was provided by the initial reporter: material no: 309657, batch no: unknown.Caller reported that insulin leaked out between top of syringe and needle before filling cartridge.Number of occurrences 2 in a row from same box.Did the caller insert the needle into the cartridge and encounter fill resistance? no.Product with issue - bd 3ml syringe, pn (b)(4).Product lot # unavailable, cartridge lot # is (b)(4).Did issue cause any injury? no.Did customer require medical intervention? no.

Manufacturer Narrative

H6: investigation summary.Samples for this complaint were sent by the customer; however shipment has been suspended of potentially contaminated samples due to covid-19 concerns.Therefore, bd will not be receiving samples on this complaint.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that 2 bd 60ml syringe luer-lok¿ tips experienced leakage.The following information was provided by the initial reporter: material no: 309657 batch no: unknown.Caller reported that insulin leaked out between top of syringe and needle before filling cartridge.¿ number of occurrences - 2 in a row from same box.¿ did the caller insert the needle into the cartridge and encounter fill resistance? - no.¿ product with issue - bd 3ml syringe, pn 309657.¿ product lot # - unavailable, cartridge lot # is m665454.¿ did issue cause any injury? - no.¿ did customer require medical intervention? - no.

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11381930
• MDR Text Key: 233740249
• Report Number: 1213809-2021-00104
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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: Lay User/Patient
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR