MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 26X3/8 IB; PISTON SYRINGE

Model Number	309625
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl 26x3/8 ib had the needle and syringe spin out.The following information was provided by the initial reporter: "it was reported when removing the shield the needle goes with it.Verbatim: consumer reported when removing the shield the needle goes with it.Informed to seat the needle still seeing this issue.Caller gets 12 syringes at a time.Lot #: 8327216, catalog#: 309625, date of event: (b)(6) 2020.Samples status awaiting sample:".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/18/2020.H.6.Investigation: two sealed packaged 1ml s/t syringes with needles were received, confirmed to be from batch #8327216 (p/n 309625).The samples were visually evaluated.The top web graphic was marked dg518101.The packaging evaluation confirmed that this product was manufactured in 1998 and had therefore expired in 2003.Since the product had long expired, no further testing or sample evaluation was performed.Batch #8327216 (p/n 309625) was manufactured in 1998 and no records remain to perform dhr review.This batch of product was manufactured in 1998 and expired in 2003.It was produced before the udi requirements went into effect requiring expiration date to be printed on individual packages.Investigation cannot be performed for reported defects of expired product.
Event or Problem Description
It was reported that syringe 1ml s/t w/ndl 26x3/8 ib had the needle and syringe spin out.The following information was provided by the initial reporter: "it was reported when removing the shield the needle goes with it.Verbatim: consumer reported when removing the shield the needle goes with it.Informed to seat the needle still seeing this issue.Caller gets 12 syringes at a time.Lot #: 8327216, catalog#: 309625, date of event: 08/10/2020, samples status awaiting sample:".

• Brand Name: SYRINGE 1ML S/T W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10475383
• Report Number: 1213809-2020-00586
• Device Sequence Number: 3546107
• Product Code: FMF
• UDI-Device Identifier: 30382903096252
• UDI-Public: 30382903096252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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): 10/01/2020

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: 309625
• Device Catalogue Number: 309625
• Device Lot Number: 8327216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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