MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SLIP TIP STERILE SYRINGE; PISTON SYRINGE

Catalog Number	302833
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one (1) photo was provided by the customer for investigation.The photo shows a syringe which has part of one (1) flange broken off.A device history record (dhr) review was performed on the batch associated with this investigation.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: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of barrel / flange damaged for lot #8107603, item #302833.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review revealed a comment that stated that a keyway on the ionizer dial had become worn which caused excessive movement of the dials which led to barrels jamming in the dials on the ionizer station.This issue could have caused occasional damage to the barrels which was not detected during the in process inspections.Rationale: bd acknowledges that the photo provided by the customer shows a syringe which has a broken flange; however, as the two (2) occurrences reported by the customer would not exceed the acceptable quality limit (aql) of ¿improperly molded components ¿ defects affecting function = (b)(4) aql¿ for the batch no corrective or preventative actions are proposed in the scope of this complaint.
Event or Problem Description
It was reported that bd¿ slip tip sterile syringe flange was damaged.This occurred on 2 occasions.The following information was provided by the initial reporter: after opening the unit package, it was found that flange damaged.

• Brand Name: BD SLIP TIP STERILE SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8624154
• Report Number: 1911916-2019-00497
• Device Sequence Number: 1941780
• Product Code: FMF
• UDI-Device Identifier: 30382903028338
• UDI-Public: 30382903028338
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 302833
• Device Lot Number: 8107603
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/20/2019
• 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