MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been reported that the syringe 1 ml st bulk convenience pak has been found containing foreign matter before use.The following has been provided by the initial reporter: it was reported that particles/marks were found inside the syringes.Event description states, "complaint: the syringes had some particles/markings inside of them.".
Additional Manufacturer Narrative
Investigation: a device history review was conducted for lot number 9127543.Our records show that this is the only instance of this issue being noted during the final assembly or visual inspections.Through the visual evaluation of the submitted devices our engineers were able to determine that the mostly root cause for this foreign material is related to the manufacturing personnel.This non-conformance occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.According to our current procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.Please note that this type of defect is cosmetic and does not pose risk to the customer.
Event or Problem Description
It has been reported that the syringe 1ml st bulk convenience pak has been found containing foreign matter before use.The following has been provided by the initial reporter: it was reported that particles/marks were found inside the syringes.Event description states, "complaint : the syringes had some particles/markings inside of them.".

• Brand Name: SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 8927941
• Report Number: 9610847-2019-00536
• Device Sequence Number: 1948353
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/10/2019

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: 08/31/2023
• Device Catalogue Number: 309701
• Device Lot Number: 9127543
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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