MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 21 G X 1 IN., 3 ML; PISTON SYRINGE

Model Number	305273
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while using bd integra¿ retracting safety syringe with 21 g x 1 in., 3 ml the needle retracted.The following information was provided by the initial reporter: syringe was defective.Customer drew up the medication, when customer's wife went to administer medication in left buttox they heard a pop.Needle had broke off in customer.There was a lot of blood.Customer went to er, ultrasound did not locate needle.At er they did small incision and attempted to locate needle with tweezers with no luck.Went to or next day and did pre-operation x-ray and could not locate needle.Surgeon sewed up incision and took apart the defective syringe.Upon taking apart the syringe it was found that the needle had retracted into the syringe.Customer was given a stitch for the incision and prescribed antibiotics as a result.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-may-2023.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the stopper was cut through by the cutter as designed and the syringe components were taken apart with the spring missing.Please note that integra product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Since the reported defect is customer awareness and not a true defect, no corrective actions are necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.H3 other text : see h10.
Event or Problem Description
It was reported while using bd integra¿ retracting safety syringe with 21 g x 1 in., 3 ml the needle retracted.The following information was provided by the initial reporter: syringe was defective.Customer drew up the medication, when customer's wife went to administer medication in left buttox they heard a pop.Needle had broke off in customer.There was a lot of blood.Customer went to er, ultrasound did not locate needle.At er they did small incision and attempted to locate needle with tweezers with no luck.Went to or next day and did pre-operation x-ray and could not locate needle.Surgeon sewed up incision and took apart the defective syringe.Upon taking apart the syringe it was found that the needle had retracted into the syringe.Customer was given a stitch for the incision and prescribed antibiotics as a result.

• Brand Name: BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 21 G X 1 IN., 3 ML
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17000026
• Report Number: 1213809-2023-00567
• Device Sequence Number: 19443419
• Product Code: MEG
• UDI-Device Identifier: 30382903052739
• UDI-Public: (01)30382903052739
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Expiration Date: 03/31/2024
• Device Model Number: 305273
• Device Catalogue Number: 305273
• Device Lot Number: 9093530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown