MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	305272
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 3 bd integra" 3 ml syringes with detachable needles experienced leakage at the connection site.The following information was provided by the initial reporter: spouse and consumer reported during the last 3 injections the medication has leaked out of the syringes all over the consumer.Stated it's where the needle is threaded into the syringe that leaks medication.Stated the pharmacy provided the syringes in a clear bag, unable to provide lot #.Lot # unknown cat # 305272.Date of event: (b)(6) 2020.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 4322827.D4: medical device expiration date: 2019-11-30.D10: device available for eval? yes.D10: returned to manufacturer on: 2020-12-10.H4: device manufacture date: 2014-11-18.H6: investigation summary: two 3ml integra syringes in fully sealed blister packs confirmed to be from batch 4322827 (p/n 305272) were received and evaluated.It was observed the hubs were not fully secured to the syringe.Please note, the product from batch 4322827 was expired as of 2019/11/30 and bd does not make claims about the performance or efficacy of expired products.The reported defect was not identified in the samples received.Furthermore, 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.
Event or Problem Description
It was reported that 3 bd integra¿ 3 ml syringes with detachable needles experienced leakage at the connection site.The following information was provided by the initial reporter: spouse and consumer reported during the last 3 injections the medication has leaked out of the syringes all over the consumer.Stated it's where the needle is threaded into the syringe that leaks medication.Stated the pharmacy provided the syringes in a clear bag, unable to provide lot #.Lot # unknown.Cat # 305272.Date of event: (b)(6) 2020.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10796348
• Report Number: 1213809-2020-00777
• Device Sequence Number: 2322351
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: 4322827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1