MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML ST BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that before use scale marking issues were discovered with a bd syringe 1ml st bulk convenience pak.The following information was provided by the initial reporter:.Material no.309701, batch no.8274580.(2of2).It was reported that there an issue with the 1 ml bd syringes slip tip tray.A scale marking issue.Per response initial reporters email: illegible graduated markings were noticed on 1ml bd syringe.
Additional Manufacturer Narrative
Investigation: one loose 1ml syringe was received and evaluated.It was observed the scale markings were very dark due to excess ink on the syringe and was rejectable per product specification.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 potential root cause for the smeared print defect is associated with the marking process.Most likely a swollen pad roll was applying excess pressure and causing the print to smear.
Event or Problem Description
It was reported that before use scale marking issues were discovered with a bd syringe 1ml st bulk convenience pak.The following information was provided by the initial reporter:.Material no.309701, batch no.8274580.(2of2).It was reported that there an issue with the 1 ml bd syringes slip tip tray.A scale marking issue.Per response initial reporters email: illegible graduated markings were noticed on 1ml bd syringe.

• Brand Name: BD SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8732585
• Report Number: 1213809-2019-00656
• Device Sequence Number: 2573208
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980580
• 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): 08/08/2019

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: 07/31/2023
• Device Catalogue Number: 309701
• Device Lot Number: 8211651
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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