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U.S. Department of Health and Human Services

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

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BECTON DICKINSON UNSPECIFED BD POSIFLUSH SYRINGE; VASCULAR ACCESS FLUSH Back to Search Results
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.
 
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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 Key13509763
MDR Text Key286596707
Report Number2243072-2022-00187
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
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 NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received02/10/2022
Supplement Dates Manufacturer Received03/25/2022
Supplement Dates FDA Received04/15/2022
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 Number1
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