MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 30ML LS S/C 56; PISTON SYRINGE

Catalog Number	302833
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
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 a cracked barrel and foreign matter occurred before use with syringes 30 ml ls s/c 56.The following information was provided by the initial reporter, "it's found that the barrel tip was cracked, there was white material in side of the barrel and the plunger was quite difficult to move.There were 3 syringes as such." (unused syringes).
Additional Manufacturer Narrative
Investigation summary: one sample and two photos were provided by the customer for investigation.Visual analysis of the returned sample showed that the syringe tip was not properly molded in that the tip was not fully formed and that there were small streaks in the syringe tip and shoulder which gave the appearance of foreign matter.There was also a partial crack in the syringe barrel near the tip where the syringe did not get properly formed.The customer also reported difficult plunger movement so the plunger was fully extended and depressed with no difficulty observed.Two photos were provided by the customer.One photo shows a side view of the syringe tip showing that it is not formed properly.The second photo shows the syringe viewed from the bottom (looking up at the tip) which shows what appears to be white foreign matter in the syringe barrel shoulder between the syringe tip and the syringe body.An improperly molded syringe barrel can be the result of incorrect pressure, time or temperature during the molding process.Inspections are performed every four hours on one complete shot of parts.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.
Event or Problem Description
It was reported that a cracked barrel and foreign matter occurred before use with syringes 30ml ls s/c 56.The following information was provided by the initial reporter, "it's found that the barrel tip was cracked, there was white material in side of the barrel and the plunger was quite difficult to move.There were 3 syringes as such." (unused syringes).

• Brand Name: SYRINGE 30ML LS S/C 56
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8709159
• Report Number: 1911916-2019-00593
• Device Sequence Number: 11194739
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 06/27/2019
• 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