MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES 3/10ML 12.7MM X 29G; PISTON SYRINGE

Model Number	323000
Medical Device Problem Codes	Break (1069); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd pet syringes 3/10ml 12.7mm x 29g, a plunger was found broken and non sterile.The following information was provided by the initial reporter: batch#: 1102439, material#: 323000.It was reported that there was a broken plunger rod and cap.The syringe was not used and was received broken out of the package.The inner package (bag) and outer packaging (box) showed no signs of damage.Product has been saved if needed.
Additional Manufacturer Narrative
H6: investigation summary: customer returned several images of a vet syringe.The thumb press has been broken off the end of the plunger.Additionally, the plunger cap has been broken, with cracks and shards missing from its surface.A review of the device history record was completed for batch # 1102439 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was able to confirm the customer¿s indicated failure of a damaged plunger cap.Based on the images received, bd was able to confirm the customer¿s indicated failure of a broken plunger rod.Root cause for this defect cannot be determined.
Event or Problem Description
It was reported while using bd pet syringes 3/10ml 12.7mm x 29g a plunger was found broken and non sterile.The following information was provided by the initial reporter: batch# 1102439 material# 323000.It was reported that there was a broken plunger rod and cap.The syringe was not used and was received broken out of the package.The inner package (bag) and outer packaging (box) showed no signs of damage.Product has been saved if needed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-feb-07.H6: investigation summary a vet syringe from lot#: 1102439 was returned.The provided syringe exhibited the same condition observed in the photos initially provided.Customer returned several images of a vet syringe.The thumb press has been broken off the end of the plunger.Additionally, the plunger cap has been broken, with cracks and shards missing from its surface.A review of the device history record was completed for batch#: 1102439 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was able to confirm the customer¿s indicated failure of a broken plunger rod.Root cause for this defect cannot be determined.
Event or Problem Description
It was reported while using bd pet syringes 3/10ml 12.7mm x 29g a plunger was found broken and non sterile.The following information was provided by the initial reporter: batch#: 1102439, material#: 323000.It was reported that there was a broken plunger rod and cap.The syringe was not used and was received broken out of the package.The inner package (bag) and outer packaging (box) showed no signs of damage.Product has been saved if needed.

• Brand Name: BD PET SYRINGES 3/10ML 12.7MM X 29G
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13359759
• Report Number: 1920898-2022-00039
• Device Sequence Number: 1647493
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 1102439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/11/2022; 03/16/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/25/2022; 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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