MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML ST BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309701
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8338895.Medical device expiration date: 2023-11-30.Device manufacture date: 2019-01-02.Medical device lot #: 9003600.Medical device expiration date: 2023-12-31.Device manufacture date: 2019-02-21.Medical device lot #: 9037699.Medical device expiration date: 2023-08-31.Device manufacture date: 2019-03-01.Medical device lot #: 9037716.Medical device expiration date: 2023-08-31.Device manufacture date: 2019-03-01.Medical device lot #: 9037717.Medical device expiration date: 2023-09-30.Device manufacture date: 2019-03-01.Medical device lot #: 9091734.Medical device expiration date: 2023-08-31.Device manufacture date: 2019-05-15.Medical device lot #: 9127543.Medical device expiration date: 2023-08-31.Device manufacture date: 2019-05-30.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 an unspecified number of syringe 1ml st bulk convenience pak experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.309701, batch no.8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543.Per email: we need to return all these syringes from bd, as they have a strange white residue within the top of every syringe.Bd 1ml syringe slip tip conv tray.Lot #: 8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543.
Event or Problem Description
It was reported that an unspecified number of syringe 1ml st bulk convenience pak experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.309701 batch no.8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543.Per email: we need to return all these syringes from bd, as they have a strange white residue within the top of every syringe.Bd 1ml syringe slip tip conv tray lot # 8338895, 9003600, 9037699, 9037716, 9037717, 9091734 and 9127543.
Additional Manufacturer Narrative
H.6.Investigation: one photo and 40 loose 1ml syringes were received and evaluated.All the samples received were observed to have cloudy tips and four of the samples were also observed to have slightly rolled scales.All the samples received were acceptable per product specification.Cloudy tips are a result of normal molding process.Over time a small amount of plastic build-up or residue occurs in the mold causing this defect.It is remedied by polishing the mold.The cloudy tip defect is cosmetic and does not pose risk to the customer.Cloudy tips are a result of the normal molding process.The potential root cause for the rolled scale defect is associated with the printing process.Since the cloudy tip defects observed are considered cosmetic and acceptable, no corrective actions are necessary.Since the rolled scale defects observed are within the acceptable limits, no corrective actions are necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8899499
• Report Number: 1213809-2019-00832
• Device Sequence Number: 2001081
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 309701
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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