MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFED BD POSIFLUSH SYRINGE; VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified bd posiflush syringe was cracked.The following information was provided by the initial reporter: "customer has documented multiple cracked syringes, on the barrel of the syringe.".

Event Description

It was reported that an unspecified bd posiflush syringe was cracked.The following information was provided by the initial reporter: "customer has documented multiple cracked syringes, on the barrel of the syringe.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-mar-2022.H.6.Investigation: it was reported there were cracked syringe barrels.To aid in the investigation, three samples with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed.The samples returned are used 30ml luer lock syringes with cracked barrels.No other defects or imperfections were observed.The photo provided shows a syringe with a drug in it.This defect could occur if there was a jam during the assembly process inducing the damage to the syringe barrel.As no material or lot number was provided, a device history record review could not be completed.Verification of the assembly process was performed.The settings were correct, the alignment of the rails and conveyors was good, and the flow of product was acceptable.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h.10.

• Brand Name: UNSPECIFED BD POSIFLUSH SYRINGE
• Type of Device: VASCULAR ACCESS FLUSH
• 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: 13509763
• MDR Text Key: 286596707
• Report Number: 2243072-2022-00187
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1