MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE SLIP TIP; 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	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).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 was reported that bd¿ 3ml syringe slip tip is missing measurement lines.This was discovered before use.The following information was provided by the initial reporter: material no.: 309656 batch no.: 9002521.It was reported that the syringes are missing the measurement lines."verbatim: we just had another client wanting to return syringes from the same lot and expiry.".
Additional Manufacturer Narrative
Investigation: two photos were received and evaluated.One photo displayed an opened blister pack from batch 9002521 (p/n309656).One photo displayed two loose 3ml syringes with varying degrees of missing and rolled 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.The printing components involved in the rolled scale were replaced 10/14/2019.For insufficient containment, corrective and preventive action, capa#753644, was opened and implemented 8/26/2019.Dhr was performed and all visual inspections were performed as per requirement and a quality notification related to the complaint defect was issued.
Event or Problem Description
It was reported that bd¿ 3ml syringe slip tip is missing measurement lines.This was discovered before use.The following information was provided by the initial reporter: material no.: 309656, batch no.: 9002521.It was reported that the syringes are missing the measurement lines.Verbatim: we just had another client wanting to return syringes from the same lot and expiry.

• Brand Name: BD 3ML SYRINGE SLIP TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9213649
• Report Number: 1213809-2019-01057
• Device Sequence Number: 2423744
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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