MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SLIP-TIP DISPOSABLE SYRINGE WITH SLIP TIP; PISTON SYRINGE

Catalog Number	301604
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that before use of the bd¿ slip-tip disposable syringe with slip tip there was foreign matter in the syringe.As reported by customer: "facility found more of the stringy substance in the 10ml slip tip syringes".Customer text: bd team, note that our facility found more of the stringy substance in the 10ml slip tip syringes this morning.The facility uses these syringes for intrathecal use.What is bd¿s position on this issue ¿ specific for intrathecal use? please advise ¿ as this issue is escalating within intermountain.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.
Event or Problem Description
It was reported that before use of the bd¿ slip-tip disposable syringe with slip tip there was foreign matter in the syringe.As reported by customer: "facility found more of the stringy substance in the 10ml slip tip syringes".Customer text: bd team, note that our facility found more of the stringy substance in the 10ml slip tip syringes this morning.The facility uses these syringes for intrathecal use.What is bd¿s position on this issue ¿ specific for intrathecal use? please advise ¿ as this issue is escalating within intermountain.

• Brand Name: BD SLIP-TIP DISPOSABLE SYRINGE WITH SLIP TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8443882
• Report Number: 1213809-2019-00376
• Device Sequence Number: 3057539
• Product Code: FMF
• UDI-Device Identifier: 30382903016045
• UDI-Public: 30382903016045
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 03/27/2019

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: 301604
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other