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

Catalog Number	309572
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Illinois, usa has been used as a placeholder based on the reported phone area code.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 the bd luer-lok¿ syringe with the bd precisionglide¿ needle was blocked during use.The following information was provided by the initial reporter: "we have used 7 needles out of this batch.The one i used tonight i needed to use all my power to push down.I couldn't give him the rest of the needed medicine because it wouldn't move.".
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with the bd precisionglide¿ needle was blocked during use.The following information was provided by the initial reporter: "we have used 7 needles out of this batch.The one i used tonight i needed to use all my power to push down.I couldn't give him the rest of the needed medicine because it wouldn't move.".
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported the needle is blocked.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two packaging blister top webs.A device history record review was completed for provided material number 309572, lot number 1342380.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1342380 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15899857
• Report Number: 1213809-2022-01124
• Device Sequence Number: 17471973
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: (01)00382903095728
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2022

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: Lay User/Patient
• Device Catalogue Number: 309572
• Device Lot Number: 1342380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown