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

Model Number 192-N251S

Device Problem Partial Blockage (1065)

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

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 mckesson prevent sg was unable to deliver medication.The following information was provided by the initial reporter : it was reported by the distributor that it is difficult to push medication through the needle.Date of event : unknown.

Manufacturer Narrative

H.6.Investigation: it was reported that it is difficult to push medication though the needles.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 with device history record analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that 1 mckesson prevent sg was unable to deliver medication.The following information was provided by the initial reporter : it was reported by the distributor that it is difficult to push medication through the needle.Date of event : unknown.

• 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: 13869098
• MDR Text Key: 287792225
• Report Number: 1213809-2022-00151
• 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: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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
• Device Operator: Other
• Device Model Number: 192-N251S
• Device Catalogue Number: 306616
• Device Lot Number: 1341422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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