MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 30ML SLIP TIP SYRINGE; PISTON SYRINGE

Catalog Number	302833
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8107603, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-17.Medical device lot #: 8082819, medical device expiration date: 2023-04-30, device manufacture date: 2018-03-23.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ 30ml slip tip syringe plunger rod broke.This occurred on 20 occasions before use.The following information was provided by the initial reporter: 20 syringes were noticed with the end of plunger rod broken during priming.No injury on the end user.
Additional Manufacturer Narrative
H.6.Investigation: five (5) samples and one (1) photo were provided by the customer for investigation.The returned samples were visually examined using unaided vision.All five (5) samples have a flange broken off on one (1) side.Additionally, all five (5) samples shows similar cracks near where the flange broke off indicating that all the barrels were subjected to a similar force.The photo shows three (3) syringes which have part of one (1) flange broken off.The dhr review on batch 8107603 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.The dhr review on batch 8082819 did not reveal any defects or issues reported and no quality notifications were issued; however, as this batch was produced before batch 8107603 it is possible that the condition reported in the batch 8107603 already existed and was not noticed by production associates.H3 other text : see h.10.
Event or Problem Description
It was reported that bd¿ 30ml slip tip syringe plunger rod broke.This occurred on 20 occasions before use.The following information was provided by the initial reporter: 20 syringes were noticed with the end of plunger rod broken during priming.No injury on the end user.

• Brand Name: BD 30ML SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8852532
• Report Number: 1911916-2019-00763
• Device Sequence Number: 13889827
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 302833
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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