MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number 309570

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.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 Description

It was reported that an unspecified number of syringe 3ml ll w/ndl 25x5/8 rb experienced a needle that broke/detached, and a loose needle which was noted during use.The following information was provided by the initial reporter: material no: 309570 batch no: unknown.309570 - it was reported the needle is disconnecting from the syringe at the base, either snapping off and seems to be loose.Caller states this has occured with about 5 or 6 units.Lot number(s)/serial number(s) were not available at this time for either catalog number as the caller needed to retrieve this information from the staff.The date of incidents for both catalog numbers are not known.

Manufacturer Narrative

H.6.Investigation: 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.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringe 3ml ll w/ndl 25x5/8 rb experienced a needle that broke/detached, and a loose needle which was noted during use.The following information was provided by the initial reporter: material no: 309570, batch no: unknown.309570: it was reported the needle is disconnecting from the syringe at the base, either snapping off and seems to be loose.Caller states this has occured with about 5 or 6 units.Lot number(s)/serial number(s) were not available at this time for either catalog number as the caller needed to retrieve this information from the staff.The date of incidents for both catalog numbers are not known.

• Brand Name: SYRINGE 3ML LL W/NDL 25X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9324562
• MDR Text Key: 191111883
• Report Number: 1213809-2019-01143
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: 30382903095705
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

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
• Device Operator: Other
• Device Catalogue Number: 309570
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other