MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number	309572
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: an invalid lot # of 0065936 has been provided.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 or Problem Description
It was reported that 74 bd 3 ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced missing scale markings and scale marking issues which was noted prior to use.The following information date received for intake: (b)(6) 2020.Material no: 309572, batch no: 0065936.During production set up on 9/1/2020, several 3 ml bd syringes were found to have no markings to indicate volume.A technician went through all syringes from this lot on site, and found, out of approximately 800, there were 74 without the necessary markings.Another technician said that they had also encountered one of these syringes earlier that day.
Event or Problem Description
It was reported that 74 bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needles experienced missing scale markings and scale marking issues which was noted prior to use.The following information date received for intake: (b)(6) 2020.Material no: 309572, batch no: 0065936.During production set up on (b)(6) 2020, several 3 ml bd syringes were found to have no markings to indicate volume.A technician went through all syringes from this lot on site, and found, out of approximately 800, there were 74 without the necessary markings.Another technician said that they had also encountered one of these syringes earlier that day.
Additional Manufacturer Narrative
H.6.Investigation: one photo and ten 3ml syringes in fully sealed blister packs confirmed to be from batch 0065936 (p/n 309657) were received and evaluated.It was observed there was no print on any of the barrels, which was rejectable per product specification.Potential root cause for the missing print defect is associated with the marking process.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.H3 other text : see h.10.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10578318
• Report Number: 1213809-2020-00656
• Device Sequence Number: 11733824
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Model Number: 309572
• Device Catalogue Number: 309572
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/26/2020
• 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