MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SYRINGE TIP CAP BULK STERILE CONVENIENCE PACK; PISTON SYRINGE

Catalog Number	305819
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone#: unknown.Initial reporter e-mail: unknown.The customer's address is unknown.(b)(6), usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the consumer allegedly developed hepatitis c and aids after using the bd¿ syringe tip cap bulk sterile convenience pack.No further information was provided.The following information was provided by the initial reporter: "i am.A victim of hep c that your infected needles and aids that i got from using your infected: no cobalt irradiated not sterile product.".
Event or Problem Description
It was reported that the consumer allegedly developed hepatitis c and aids after using the bd¿ syringe tip cap bulk sterile convenience pack.No further information was provided.The following information was provided by the initial reporter: "i am.A victim of hep c that your infected needles and aids that i got from using your infected :no cobalt irradiated not sterile product.".
Additional Manufacturer Narrative
H6.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history record review was not performed as the lot number is "unknown" for this complaint.

• Brand Name: BD¿ SYRINGE TIP CAP BULK STERILE CONVENIENCE PACK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15678834
• Report Number: 2243072-2022-01844
• Device Sequence Number: 5960858
• Product Code: FMF
• UDI-Device Identifier: 00382903058198
• UDI-Public: (01)00382903058198
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 305819
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown