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

Model Number	305274
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7001879, medical device expiration date: 2021-12-31, device manufacture date: 2017-01-01, medical device lot #: 7177705, medical device expiration date: 2022-06-30, device manufacture date: 2017-06-26." a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use with a bd integra¿ 3 ml syringe with detachable needle the needle breaks.The following information was provided by the initial reporter: the needles break when patients have been given injections.No serious injury however because the syringe broke whilst administering an injection to the patient it was impossible to ascertain how much medication had been administered to the patient.
Event or Problem Description
It was reported that during use with a bd integra¿ 3 ml syringe with detachable needle the needle breaks.The following information was provided by the initial reporter: the needles break when patients have been given injections.No serious injury however because the syringe broke whilst administering an injection to the patient it was impossible to ascertain how much medication had been administered to the patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation?: yes d.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: eight 100-count shelf cartons from batch 7177705 (p/n (b)(6)) were received and evaluated.No visual defects were observed.The retraction mechanism was activated on all 800 syringes with no functional defects observed.Based on the verbatim, it was unclear if the device was used as intended.Ince the reported defect was not identified in the samples received, no corrective actions are required at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint 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: 10365719
• Report Number: 1213809-2020-00508
• Device Sequence Number: 17108647
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Other
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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