MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 22 G X 1 1/2 IN. BD INTEGRA NEEDLE; PISTON SYRINGE

Catalog Number	305313
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause description: root cause is undetermined.Rationale: no sample, lot, or batch provided.
Event or Problem Description
It was reported that after use of the 22 g x 1 1/2 in.Bd integra¿ needle the needle failed to retract post im injection leaving exposed needle.The following information was provided by the initial reporter: needle failed to retract post im injection leaving exposed needle.

• Brand Name: 22 G X 1 1/2 IN. BD INTEGRA NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8558014
• Report Number: 1911916-2019-00416
• Device Sequence Number: 13862707
• Product Code: MEG
• UDI-Device Identifier: 30382903053132
• UDI-Public: 30382903053132
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305313
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other