Catalog Number 303310 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
Chemical Exposure (2570)
|
Event Date 12/04/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that syringe 20ml ll s/c 50 was cracked and leaked.The following information was provided by the initial reporter: material no: (b)(4).Batch no: 0136387, 0098741. it was reported that 3 syringes cracking down the right side of the syringe. verbatim: report of 3 syringes cracking down the right side of the syringe.Sprayed tech in the face w/ venofor(?), he sought medical attn, initials jmm, week of dec 4th she has the syringes available to return.
|
|
Event Description
|
It was reported that syringe 20ml ll s/c 50 was cracked and leaked.The following information was provided by the initial reporter: material no: 303310 batch no: 0136387, 0098741. it was reported that 3 syringes cracking down the right side of the syringe. verbatim: report of 3 syringes cracking down the right side of the syringe.Sprayed tech in the face w/ venofor(?), he sought medical attn, initials jmm, week of (b)(6) she has the syringes available to return.
|
|
Manufacturer Narrative
|
H.6.Investigation: it was received 3 photographs in which it is possible to observe in each one of this a syringe with the damage barrel, the photographs shows the blister paper too in which its possible to observe the code 303310 and the batches 0136387 and 0098741 the same that the customer reported.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.The damage to the syringe can be generated by excess syringes assembled in the hopper, as there is accumulation of syringe assembled in the elevator, this generated obstruction and damage to the syringe assembled.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|