MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 22X1-1/2 RB TW; PISTON SYRINGE

Model Number	305313
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 needle integra 22x1-1/2 rb tw experienced a safety mechanism failure.The following information was provided by the initial reporter: nursing staff have reported a malfunction with a bd syringe/needle on (b)(6) 2021.There was a malfunction with the needle and it failed to retract.No harm to patient due to malfunction.Due to the nature of the malfunction of the syringe and needle it appeared that approximately 0.1 ml to 0.2 ml of lai failed to be administered.
Event or Problem Description
It was reported that the needle integra 22x1-1/2 rb tw experienced a safety mechanism failure.The following information was provided by the initial reporter: nursing staff have reported a malfunction with a bd syringe/needle on (b)(6) 2021.There was a malfunction with the needle and it failed to retract.No harm to patient due to malfunction.Due to the nature of the malfunction of the syringe and needle it appeared that approximately 0.1 ml to 0.2 ml of lai failed to be administered.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 305313 and lot number 8141884.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.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.
Event or Problem Description
It was reported that the needle integra 22x1-1/2 rb tw experienced a safety mechanism failure.The following information was provided by the initial reporter: nursing staff have reported a malfunction with a bd syringe/needle on aug 31, 2021.There was a malfunction with the needle and it failed to retract.No harm to patient due to malfunction.Due to the nature of the malfunction of the syringe and needle it appeared that approximately 0.1 ml to 0.2 ml of lai failed to be administered.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-mar-17.Investigation summary it was reported that there was a malfunction and the needle failed to retract.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.The sample has the plastic shield and a needle hub, but there is no spring or needle.No further analysis could be completed.A device history record review was completed for provided material number 305313, lot number 8141884.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed, but a probable root cause could not be offered.

• Brand Name: NEEDLE INTEGRA 22X1-1/2 RB TW
• 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: 12555234
• Report Number: 1911916-2021-01041
• Device Sequence Number: 11038184
• Product Code: MEG
• UDI-Device Identifier: 30382903053132
• UDI-Public: 30382903053132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• 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): 03/18/2022

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: 07/31/2023
• Device Model Number: 305313
• Device Catalogue Number: 305313
• Device Lot Number: 8141884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 03/18/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/26/2021; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2018
• 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