MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML LL; PISTON SYRINGE

Catalog Number	305283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The lot# is unknown, but the possible lot# information is as follows: medical device lot #: 6320741, medical device expiration date: 2021-10-31, device manufacture date: 2016-11-15.Medical device lot #: 7146782, medical device expiration date: 2022-05-31, device manufacture date: 2017-05-26.Medical device lot #: 7334976, medical device expiration date: 2022-11-30, device manufacture date: 2017-11-30.Medical device lot #: 5327742, device manufacture date: 2015-11-23.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 a needle retraction issue occurred during use with a syringe integra 3ml ll.The following information was provided by the initial reporter, "i have just received a complaint/concern from one of our customers on the integra syringes (305283).There were 6 boxes purchased in february, 2019.The complaint is that two of the syringes have snapped when used on a client.They do not want to continue use and have expressed their concern.Has there been a recall on this item? " 2 occurrences were reported.The dates, times, and patient information were not given.Costumer provided multiple lot numbers, but is not sure which are associated with the syringes in question.6320741 (2 boxes), 7146782, 7334976 (2 boxes), 5327742.
Event or Problem Description
It was reported that a needle retraction issue occurred during use with a syringe integra 3ml ll.The following information was provided by the initial reporter, "i have just received a complaint/concern from one of our customers on the integra syringes (305283).There were 6 boxes purchased in february, 2019.The complaint is that two of the syringes have snapped when used on a client.They do not want to continue use and have expressed their concern.Has there been a recall on this item? " 2 occurrences were reported.The dates, times, and patient information were not given.Costumer provided multiple lot numbers, but is not sure which are associated with the syringes in question.6320741 (2 boxes) 7146782 7334976 (2 boxes) 5327742.
Additional Manufacturer Narrative
H.6.Investigation: it is unknown from description what the reported issue with the product is.Please note that this product has a retractable needle safety feature as part of its design.Since no samples displaying the reported condition were received a potential root cause could not be defined.A device history record review showed no rejected inspections or quality issues during the production of the all possible lot number reported that could have contributed to the reported defect.H3 other text : see h.10.

• Brand Name: SYRINGE INTEGRA 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8838813
• Report Number: 1213809-2019-00781
• Device Sequence Number: 13532789
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/30/2019

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: Other
• Device Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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