MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 309597

Device Problems Difficult to Remove (1528); Inadequate User Interface (2958)

Patient Problem No Code Available (3191)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ slip tip syringe with attached needle shield is hard to remove and it is difficult to push the needle into the patients leg.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309597, batch no: 8059526.It was reported that the needle shields are difficult to remove and that the user has scratched themselves in the past as a result.It was also reported that user was having difficulty pushing the needle into their leg.Event description per customer's complaint form states, "a report was received 28feb2019 via med info.With shire ae line transferred a patient that takes gattex for the treatment of short bowel syndrome.The caller stated "i have been using gattex now for 8 months, but this last month i have i have noticed that when i push the needle into my leg the skin on my leg is so tough it's like there is scar tissue under there.I only inject the medication in my legs.It's really hard trying to take the caps off the needles too.I can't take caps off due to my arthritis in my middle finger, it does not bend well." no further information provided.Ae filed for skin is tough feels like scar tissue is under skin.Pc filed for patient having difficulty taking the caps off the needle.Lot# unknown.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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 Description

It was reported that bd¿ slip tip syringe with attached needle shield is hard to remove and it is difficult to push the needle into the patients leg.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 309597 batch no: 8059526 it was reported that the needle shields are difficult to remove and that the user has scratched themselves in the past as a result.It was also reported that user was having difficulty pushing the needle into their leg.Event description per customer's complaint form states, "a report was received 28feb2019 via med info.With shire ae line transferred a patient that takes gattex for the treatment of short bowel syndrome.The caller stated "i have been using gattex now for 8 months, but this last month i have i have noticed that when i push the needle into my leg the skin on my leg is so tough it's like there is scar tissue under there.I only inject the medication in my legs.It's really hard trying to take the caps off the needles too.I can't take caps off due to my arthritis in my middle finger, it does not bend well." no further information provided.Ae filed for skin is tough feels like scar tissue is under skin.Pc filed for patient having difficulty taking the caps off the needle.Lot# unknown.".

• Brand Name: BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8493500
• MDR Text Key: 146272737
• Report Number: 1213809-2019-00419
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: 30382903095972
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 309597
• Device Lot Number: 8059526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other