MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 30ML LS S/C 56; 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	05/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: unknown.Investigation summary: one (1) photo was provided by the customer for investigation.The photo shows a syringe which has a stopper that appears to be ¿rolled¿ and not inserted properly.Rolled stoppers can occur intermittently during assembly of the syringe when the plunger rod and stopper subassembly are pressed into the syringe barrel.A misalignment between the barrel and subassembly can cause the rolled stopper.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of stopper defective / damaged for lot #8107603, item #302833.Root cause description: rolled stoppers can occur intermittently during assembly of the syringe when the plunger rod and stopper subassembly are pressed into the syringe barrel.A misalignment between the barrel and subassembly can cause the rolled stopper.Rationale: bd acknowledges that the photo provided by the customer appears to show a syringe which has a rolled stopper; however, as the two (2) occurrences reported by the customer would not exceed the acceptable quality limit (aql) of ¿rolled stoppers = 0.10% 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 there were 2 occurrences where the stopper was deformed with a bd syringe 30ml ls s/c 56.The following information was provided by the initial reporter, translated from (b)(6) to english: after opening the unit package, it was found that stopper was out of shape.

• Brand Name: BD SYRINGE 30ML LS S/C 56
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8629537
• Report Number: 1911916-2019-00507
• Device Sequence Number: 1748414
• 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,health professional,o
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2019
• Initial Report FDA Received Date: 05/21/2019
• 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