MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML S/T W/NDL 26X5/8 RB; PISTON SYRINGE

Catalog Number 309597

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Material no.309597 batch no.9070752.It was reported that during use of the syringe 1ml s/t w/ndl 26x5/8 rb the needles were defective.The following information was provided by the initial reporter: "patient states a lot of the needles used to inject the medication were defective and now she is short about a weeks worth.It is unknown if the patient still has the pens on hand.It is also unknown if a dose was missed.Expiration date is unknown.".

Manufacturer Narrative

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

Event Description

Material no.309597, batch no.9070752.It was reported that during use of the syringe 1ml s/t w/ndl 26x5/8 rb the needles were defective.The following information was provided by the initial reporter: "patient states a lot of the needles used to inject the medication were defective and now she is short about a weeks worth.It is unknown if the patient still has the pens on hand.It is also unknown if a dose was missed.Expiration date is unknown.".

• Brand Name: SYRINGE 1ML S/T W/NDL 26X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9262639
• MDR Text Key: 195883674
• Report Number: 1213809-2019-01088
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: 30382903095972
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 309597
• Device Lot Number: 9070752
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other