MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 60ML S/T LATEX FREE CONFIGURE; PISTON SYRINGE

Model Number	309654
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that syringe 60ml s/t latex free configure had a bent tip.The following information was provided by the initial reporter: "it was reported that the tip was bent.".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided material number 309654 and lot number 1005581.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 60ml s/t latex free configure had a bent tip.The following information was provided by the initial reporter: " it was reported that the tip was bent.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 7/16/2021.H.6.Investigation:it was reported that the tip was bent.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.The syringe barrel tip is damaged.No other defects or imperfections were observed.This defect could occur if there was a jam during the assembly process inducing the damage shown in the sample received.A device history record review was completed for provided material number 309654, lot number 1005581.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the assembly process was performed.No conditions that could induce a jam were observed.Alignment of the rails and conveyors were good.Product flow was acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text: see h10.
Event or Problem Description
It was reported that syringe 60ml s/t latex free configure had a bent tip.The following information was provided by the initial reporter: " it was reported that the tip was bent.".

• Brand Name: SYRINGE 60ML S/T LATEX FREE CONFIGURE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12185751
• Report Number: 1911916-2021-00689
• Device Sequence Number: 1631623
• Product Code: FMF
• UDI-Device Identifier: 30382903096542
• UDI-Public: 30382903096542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2021

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: 12/31/2025
• Device Model Number: 309654
• Device Catalogue Number: 309654
• Device Lot Number: 1005581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/17/2021; 11/05/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/05/2021; 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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