MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS MCKESSON¿ PREVENT SG; PISTON SYRINGE

Model Number 192-N251S

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported needle clogged while using mckesson¿ prevent sg.This occurred 20 times, however, no patient impact reported.The following information was provided by the initial reporter: -unable to get fluid or air thru the needle when we trying to draw up medication or inject.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-apr-2022.H6: investigation summary it was reported unable to get fluid or air thru the needles.To aid in the investigation, eleven samples were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution, all samples did not expel the solution; these needles are clogged.A device history record review was completed for provided material number 306616, columbus needle lot numbers 1214992, 1278946, 1214008, 1214997.These needle lots were used in the manufacturing of the final product lots 1341422.The review revealed there was documentation for this type of defect during the production run of lot number 1214992 for clogged needles due to silicone.It could be possible these samples are escapes from the incident that occurred while producing batch 1214992.The process to isolate affected product was reviewed, as well as the process of variations that could induce the needle clogged / blocked symptom.The processes were adjusted to prevent variations that could result in this defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported needle clogged while using mckesson¿ prevent sg.This occurred 20 times, however, no patient impact reported.The following information was provided by the initial reporter: -unable to get fluid or air thru the needle when we trying to draw up medication or inject.

• Brand Name: MCKESSON¿ PREVENT SG
• Type of Device: 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: 13971500
• MDR Text Key: 288373694
• Report Number: 1213809-2022-00171
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479248578
• UDI-Public: 10612479248578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 192-N251S
• Device Catalogue Number: 306616
• Device Lot Number: 1341422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1