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

Model Number	309571
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical 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.
Event or Problem Description
It was reported that a shot of b12 medication leaked from the threaded connection point at the tip of the bd luer-lok¿ tip syringe with bd precisionglide¿ needle during use.The following information was provided by the initial reporter: "1 syringe found to be faulty today because all of the medication spilled out at the threaded connection point at the tip of the syringe.Direct consumer home user takes 1 b12 shot every month, receives form pharmacy.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.A physical unused samples are required for leakage testing.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.Dhr could not be performed as the lot# is unknown.
Event or Problem Description
It was reported that a shot of b12 medication leaked from the threaded connection point at the tip of the bd luer-lok¿ tip syringe with bd precisionglide¿ needle during use.The following information was provided by the initial reporter: "1 syringe found to be faulty today because all of the medication spilled out at the threaded connection point at the tip of the syringe.Direct consumer home user takes 1 b12 shot every month, receives form pharmacy.".

• Brand Name: BD LUER-LOK TIP SYRINGE 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: 9981167
• Report Number: 1213809-2020-00261
• Device Sequence Number: 19807406
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: Lay User/Patient
• Device Model Number: 309571
• Device Catalogue Number: 309571
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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