MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	305274
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter: address unavailable.Bd corporate address used.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle retracted prematurely and was thought to have come out at injection site which led to medical intervention with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter: it was reported that the consumer thought that the needle might have broken off in their buttocks.Verbatim states, "from phone call on (b)(6) 2019 14:39:14: i called pharmacist back and asked her to have consumer contact us to provide mailing address.Pharmacist stated that she does not think the consumer will pursue anything, said she seemed to be relieved when she demonstrated how the integra syringe works.Pharmacist reported on behalf of consumer, that the integra syringe needle broke off into the consumer's buttocks during injection, stated that the consumer went to the emergency room to have the needle removed.While on the phone, the consumer's spouse walked into the pharmacy and reported that her husband was taken by ambulance to the er, an ultrasound was done and the needle was not found.Consumer was not aware that the integra syringe is retractable, she will be sending the sample for evaluation.No injury or discomfort although consumer states that there is pain when the injection site it touched.Problem occurred this morning ((b)(6) "2019"), lot # 8002924, exp 12-31-2022, product # 305274.Consumer is also sending receipt for refund, will no longer use integra syringes.
Event or Problem Description
It was reported that the needle retracted prematurely and was thought to have come out at injection site which led to medical intervention with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter: it was reported that the consumer thought that the needle might have broken off in their buttocks.Verbatim states, "from phone call on (b)(6) 2019 14:39:14: i called pharmacist back and asked her to have consumer contact us to provide mailing address.Pharmacist stated that she does not think the consumer will pursue anything, said she seemed to be relieved when she demonstrated how the integra syringe works.Pharmacist reported on behalf of consumer, that the integra syringe needle broke off into the consumer's buttocks during injection, stated that the consumer went to the emergency room to have the needle removed.While on the phone, the consumer's spouse walked into the pharmacy and reported that her husband was taken by ambulance to the er, an ultrasound was done and the needle was not found.Consumer was not aware that the integra syringe is retractable, she will be sending the sample for evaluation.No injury or discomfort although consumer states that there is pain when the injection site it touched.Problem occurred this morning on ((b)(6) 2023), lot # 8002924, exp 12-31-2022, product # 305274.Consumer is also sending receipt for refund, will no longer use integra syringes.
Additional Manufacturer Narrative
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.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.

• Brand Name: BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8617749
• Report Number: 1213809-2019-00544
• Device Sequence Number: 263282
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 305274
• Device Lot Number: 8002924
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other