MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE; SYRINGE W/ NEEDLE

Catalog Number	309632
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 syringe with bd precisionglide¿ needle had sterility issues.The following information was provided by the initial reporter: material no.: 309632, batch no.: 9008885.Customer would like to know if there have been any complaints, field issues, or manufacturing deviations as there was a sterility positive for bacteria.Verbatim: as part of an ongoing investigation into a sterility positive, we are contacting the supplier of sterile materials used in our process.
Additional Manufacturer Narrative
The following fields have been updated with corrections: pma/510(k)#: k980987.
Event or Problem Description
It was reported that bd syringe with bd precisionglide¿ needle had sterility issues.The following information was provided by the initial reporter: material no.: 309632, batch no.: 9008885.Customer would like to know if there have been any complaints, field issues, or manufacturing deviations as there was a sterility positive for bacteria.Verbatim: as part of an ongoing investigation into a sterility positive, we are contacting the supplier of sterile materials used in our process.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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.Material # (b)(4), batch # (b)(4) was processed according to bd requirements for sterile devices per product specifications.No issues and no deviations occurred during the sterilization process.
Event or Problem Description
It was reported that bd syringe with bd precisionglide¿ needle had sterility issues.The following information was provided by the initial reporter: material no.: (b)(4), batch no.: (b)(4).Customer would like to know if there have been any complaints, field issues, or manufacturing deviations as there was a sterility positive for bacteria.Verbatim: as part of an ongoing investigation into a sterility positive, we are contacting the supplier of sterile materials used in our process.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: SYRINGE W/ NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8667306
• Report Number: 1213809-2019-00587
• Device Sequence Number: 254536
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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: 12/31/2023
• Device Catalogue Number: 309632
• Device Lot Number: 9008885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 05/20/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/18/2019
• 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