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

Catalog Number	309656
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the syringe 3ml ls 200 s/c has been found experiencing scale marking issues before use.The following has been provided by the initial reporter: it was reported that the syringes are missing the measurement lines.Verbatim: i just had a client call in that has a box of syringe bd 3cc luer slip tip - 200's that are missing the measurement lines.Lot # 9002521, expiry date 2023/12/31.This is not the first box from that lot that we have had clients call about.
Event or Problem Description
It has been reported that the syringe 3ml ls 200 s/c has been found experiencing scale marking issues before use.The following has been provided by the initial reporter: it was reported that the syringes are missing the measurement lines.Verbatim: i just had a client call in that has a box of syringe bd 3cc luer slip tip - 200's that are missing the measurement lines.Lot # 9002521, expiry date 2023/12/31.This is not the first box from that lot that we have had clients call about.
Additional Manufacturer Narrative
H.6.Investigation: two photos and six 3ml syringes were received and evaluated.Five were in fully sealed blister packs from batch 9002521 (p/n 309656) and one was loose.It was observed all the syringes contained varying degrees of rolled scales and missing print and were rejectable per product specification.Potential root cause for the missing print is associated with the printing process.It is likely a printing component gradually slipped out of adjustment causing the print to be applied on the incorrect position on the barrel.This is consistent with the variance of the missing scale.The potential root cause for the product being distributed is associated with insufficient containment.The missing print was discovered during manufacturing and containment actions were administered but defective product was still packaged and distributed.Corrective action, the printing components involved in the rolled scale were replaced.For insufficient containment, corrective and prevention action was opened and implemented.Capa#753644.

• Brand Name: SYRINGE 3ML LS 200 S/C
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9197135
• Report Number: 1213809-2019-01052
• Device Sequence Number: 2325631
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 309656
• Device Lot Number: 9002521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other