MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

Catalog Number	301947
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that syringe s2 10ml 21ga 1-1/2in bd china had foreign matter on 2 occasions before use.The following information was provided by the initial reporter: on (b)(6) 2020, the teacher of (b)(6) opened the package and was preparing to use the bd10ml syringe for dispensing and found that the needle had a black spot similar to "rust".
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2020-11-11.Investigation summary a device history record review was performed for provided lot number 1902153 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the physical sample, the cannula was observed rusted.It has been determined that this incident most likely resulted from incorrect storage of the product.This type of defect may result if the product is stored close to detergents and cleaning product substances like sodium hypochlorite or similar products.Our quality team will closely monitor the production process for signs of this potential defect and any emerging trends.
Event or Problem Description
It was reported that syringe s2 10ml 21ga 1-1/2in bd china had foreign matter on 2 occasions before use.The following information was provided by the initial reporter: on (b)(6) 2020, the teacher of the sixth department of cardiology of the (b)(6) university opened the package and was preparing to use the bd10ml syringe for dispensing and found that the needle had a black spot similar to "rust".

• Brand Name: SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10709332
• Report Number: 3002682307-2020-00319
• Device Sequence Number: 3232234
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• 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): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 301947
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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