MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Catalog Number	309577
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 fifty syringe 3ml ll w/ndl 21x1-1/2 rb experienced scale marking issues.The following information was provided by the initial reporter: material no: 309577, batch no: 9008856.It was reported via phone call that the customer has received reports that at least fifty syringes were found to have defective/blurred scale markings.No pts were impacted and affected samples are available.Only seeing issues with this lot.Date of occurrence is now known per customer on phone call.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that fifty syringe 3ml ll w/ndl 21x1-1/2 rb experienced scale marking issues.The following information was provided by the initial reporter: material no: 309577 batch no: 9008856.It was reported via phone call that the customer has received reports that at least fifty syringes were found to have defective/blurred scale markings.No pts were impacted and affected samples are available.Only seeing issues with this lot.Date of occurrence is now known per customer on phone call.

• Brand Name: SYRINGE 3ML LL W/NDL 21X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8567127
• Report Number: 1213809-2019-00491
• Device Sequence Number: 11147276
• Product Code: FMF
• UDI-Device Identifier: 00382903095773
• UDI-Public: 00382903095773
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 309577
• Device Lot Number: 9008856
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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